Lopid
- Product NDC
- 0071-0737
- 11-digit product format
- 000710737
- Labeler code
- 0071
- Product ID
- 0071-0737_c2888455-2200-497a-8e5a-10515dcb4f66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Parke-Davis Div of Pfizer Inc
- Application
- NDA018422
- Marketing category
- NDA
- Marketing start
- 2004-03-30
- Substance
- GEMFIBROZIL
- Active strength
- 600 mg/1
- Pharmacologic classes
- Fibric Acids [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lopid
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GEMFIBROZIL | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q8X02027X3 |
| Rxcui | 205751, 310459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0071-0737-20 | Lopid | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 23 |
| 0071-0737-30 | Lopid | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| gemfibrozil | ACTIVE INGREDIENT | Q8X02027X3 | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| gemfibrozil | ACTIVE MOIETY | Q8X02027X3 | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0071-0737 | LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | 22 | Current NDC, Legacy NDC, 2 package rows | 20240716_c48855b7-215e-453b-b3b1-a0f9dee7221f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0071-0737-20 | 00071073720 | 60 TABLET, FILM COATED in 1 BOTTLE (0071-0737-20) | 2004-03-30 | 0000-00-00 | No | No | Current |
| 0071-0737-30 | 00071073730 | 500 TABLET, FILM COATED in 1 BOTTLE (0071-0737-30) | 2004-03-30 | 0000-00-00 | No | No | Current |